Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 41
- 主要终点
- Device and Procedure-related serious adverse events
研究概览
简要总结
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
详细描述
This study is a prospective, non-randomized, parallel cohort, multi-center study of Desara® One single incision sling (SIS) compared to Desara® Blue sling systems implanted via the transobturator-route (TOR) for the treatment of women with stress urinary incontinence (SUI). The study will compare results from SIS patients (N=150) and TOR patients (N=150) at up to 40 sites for a total period of 36 months, with follow-up visits at 2 and 6 weeks, 6, 12, 18, 24 and 36 months. This study will enroll adult females who are clinically indicated for a mid-urethral implant for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ≥ 18 of age.
- •Subject agrees that she is willing and able to return for all study related procedures and evaluations.
- •Subject has provided signed informed consent.
- •Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
- •Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
- •Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:
- •A hysterectomy or
- •Tubal ligation or
- •Is otherwise incapable of pregnancy or has
- •Negative pregnancy test prior to study entry and has decided to cease childbearing
- •Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.
- •Subject is eligible to undergo laparoscopic/robotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).
排除标准
- •Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
- •Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
- •Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
- •Subject has a history of chronic opioid, or narcotic use for:
- •any other specified reason
- •Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
- •Subject is on chronic (> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).
- •Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose > 130mg/dl at screening/baseline.
- •Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.
- •Subject has active UTI which requires treatment, as determined by the Investigator.
- •Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.
- •Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).
- •The subject has had:
- •any prior surgical stress urinary incontinence treatment or
- •any prior surgery on their urethra or
- •any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair
- •any previous pelvic floor mesh use or complication
- •Subject has any of the following confounding conditions:
- •bladder stones or tumors
- •pathology that in the opinion of the Investigator would compromise implant placement
- •pathology that would limit pelvic blood supply
- •pathology that would require chemotherapy and systemic use of immunosuppressants
- •Subject has abnormal bladder capacity <300 mL.
- •Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)
- •Subject has had previous radiation therapy or brachytherapy to the pelvis.
- •Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.
- •Subject has known reaction, sensitivity or allergy to polypropylene.
研究组 & 干预措施
Desara® One
Single Incision Sling
干预措施: Desara® One Single Incision Sling (Device)
Desara® Blue
Transobturator Sling
干预措施: Desara® Blue Transobturator Sling (Device)
结局指标
主要结局
Device and Procedure-related serious adverse events
时间窗: 36 months
* Device- and/or procedure-related adverse event rates at the post-implant follow-up visits * Revision/re-surgery rates at post-implant follow-up visits * Device and/or procedure-related serious adverse events
Success rate of negative standing cough stress test (CST)
时间窗: 36 months
Negative standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound, evaluated at the 36-month post-implant follow-up visit. The success rate is defined as the proportion of subjects with a negative CST at the 36-month post-implant follow-up
次要结局
- Composite outcome success rates(6 weeks, 6, 12, 18, 24, 36 months)
- Improvement in Incontinence(6 weeks, 6, 12, 18, 24, 36 months)
- Sexual Function Assessment(6 weeks, 6, 12, 18, 24, 36 months)
- Improvement in Urinary Symptoms(6 weeks, 6, 12, 18, 24, 36 months)
- Improvement in Urge and Stress Incontinence(6 weeks, 6, 12, 18, 24, 36 months)
- Subject pain assessment(6 weeks, 6, 12, 18, 24, 36 months)
- Time to void post-implant(6 weeks, 6, 12, 18, 24, 36 months)